The present invention relates to a method, apparatus and a realistic model of a human female breast which are used to train doctors, nurses and other health professionals in the palpation method of breast examination, and is particularly useful in training women how to conduct breast self-examination.
Breast cancer is among the most common malignant tumors and is the leading cause of death from cancer among women in the United States. It is estimated that 1 out of every 15 American women will develop the disease at some time during her life, and that 20% of deaths from cancer among women are attributable to breast cancer. There has been no great reduction in the mortality rate of this disease in the past 35 years.
It is well recognized that early detection of breast cancer is the single most important variable in the successful cure and treatment of the cancer. Various methods for detecting breast cancer include angiography, ultrasonography, isotope scanning, thermography, mammography and manual palpation. All of these techniques except for manual palpation are time consuming, expensive and require the interpretation of a trained specialist. In addition, recent studies suggest that mammography itself may be a cause of breast cancer.
Of all of these techniques for detecting breast cancer, the easiest and least expensive method is manual examination. The potential effectiveness of manual examination, and particularly breast self-examination, in detecting small tumors relies on the effectiveness of manual palpation. Approximately 94% of breast cancers are potentially palpable and are candidates for early manual detection. It has been estimated that the expected death rate due to breast cancer could be halved if the size of the detected tumors could be reduced to less than about 2 cm. It has been indicated that further progress in breast cancer control is conditioned on progress in self-examination instruction, so that women are more comfortable and confident in performing breast self-examination.
The present invention is based upon the clinical and experimental evidence that a systematic approach to manual breast examination can lead to the early detection of smaller tumors through training. See the following papers, the disclosures of which are hereby specifically incorporated herein by reference: C. K. Adams et al., "Lump Detection In Simulated Human Breasts," Perception & Psychophysics, 20(3), pp. 163-167 (1976); D. C. Hall et al., "Progress In Manual Breast Examination," Cancer, Vol. 40, No. 1, July, 1977 pp. 364-370.
The present invention comprises a realistic model of the human female breast and a method and apparatus for using a preferred form of the model to train persons how to systematically conduct a manual breast examination with a high degree of confidence. The present invention is clearly distinguishable from the following commercially available devices and patents, which are believed to be the closest prior art:
Ortho Pharmaceutical Corporation has been marketing a breast cancer teaching model in the form of a human female's torso having simulated tumors embedded in the breast. This model is of extremely limited value as an effective teaching tool in that it is made of foam rubber and not at all lifelike. There is no provision made in the model, sold under the trademark "BETSI", for any means to simulate the different types of tissue found in the human breast. In addition, the model is not adapted for use with any sort of means for feeding back information to the trainee.
Spenco Medical Corporation markets a breast cancer teaching model comprising a plurality of simulated tumors within a gel-like substance shaped like a breast. The model comprises a gel-like substance within a protective fabric cover, which serves as a "skin". While this device is an improvement over "BETSI", it lacks the feel of a real breast. The gel-like substance does not have the complexity for simulating adipose, glandular and connective tissue which is found in the human female breast. Moreover, there are no means associated with the model to provide feedback information to the trainee.
U.S. Pat. No. 3,742,935 of Baessler et al. relates to a method and apparatus used in teaching palpation techniques. A pressure transducer is in pressural engagement with the skin of a patient adjacent to an area of the body which generates changes in pressure, such as blood vessels, the heart, the larynx, etc. The transducer is connected through an amplifier to a master unit and a plurality of slave units. By monitoring the output of the transducer through the amplifier, a physician or other teacher can instruct the students on the techniques of palpation by means of the slave units which reproduce the vibrations transmitted by the blood vessels, heart, larynx or other source. The method and apparatus described in this patent is of no use in teaching the palpation of passive areas of the body, such as breast tumors. Thus, while blood vessels, the heart and larynx all cause pressure displacements, such as pulses and voice vibrations, no such displacements are created by breast tumors.
U.S. Pat. No. 3,942,516 of Glynn et al. discloses a system and method for use in training persons how to control various biological functions, such as muscle activity, by means of monitoring electrical signals generated by the body, such as brain waves, differential skin temperature and muscle tension measurements. The system and method described in the patent require that electrodes be attached to the patient/trainee to monitor his physiological condition. This patent does not teach or suggest the use of a model for training purposes and its interrelationship with a trainee.
U.S. Pat. No. 3,681,787 of Perras discloses a breast prosthesis to be implanted in a woman's chest. The prosthesis contains gels of different viscosities and densities to maintain the configuration of the prosthesis, and to retain the desired consistency and appearance. It is clear that the placement of the denser, more viscous gels in the patented prosthesis is not intended to simulate the feeling to the touch of real breast tissue. Rather, the different gels of the prosthesis are to maintain the shape and appearance of the prosthesis, and not to provide a realistic feel during palpation. Moreover, this patent neither teaches nor suggests the use of the prothesis as a model for breast cancer detection training.